Job Description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide.
You'll oversee regulatory compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers the opportunity to influence global regulatory policy and drive innovation in our regulatory approaches.
REQUIREMENTS:
Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations
Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
Successful track record of regulatory submissions and agency interactions
Leadership experience managing and mentoring multi-site teams
Experience in regulatory strategy development and implementation
Demonstrated expertise in regulatory compliance and quality management systems
Advanced project management and organizational skills
Excellent verbal and written communication abilities
Effective negotiation and influencing skills
Ability to work effectively in a matrix organization
Business acumen and strategic thinking capabilities
Proficiency in standard office technology and regulatory systems
Fluency in English required; additional language skills advantageous
Ability to travel 25-50% of time, primarily international
Experience with CDMO/pharmaceutical services preferred
Knowledge of current industry trends and participation in professional associations (e.g., TOPRA, PDA)
Compensation
The salary range estimated for this position based in Ohio is $150,000.00–$218,000.00.
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide.
You'll oversee regulatory compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers the opportunity to influence global regulatory policy and drive innovation in our regulatory approaches.
REQUIREMENTS:
Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations
Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
Successful track record of regulatory submissions and agency interactions
Leadership experience managing and mentoring multi-site teams
Experience in regulatory strategy development and implementation
Demonstrated expertise in regulatory compliance and quality management systems
Advanced project management and organizational skills
Excellent verbal and written communication abilities
Effective negotiation and influencing skills
Ability to work effectively in a matrix organization
Business acumen and strategic thinking capabilities
Proficiency in standard office technology and regulatory systems
Fluency in English required; additional language skills advantageous
Ability to travel 25-50% of time, primarily international
Experience with CDMO/pharmaceutical services preferred
Knowledge of current industry trends and participation in professional associations (e.g., TOPRA, PDA)
Compensation
The salary range estimated for this position based in Ohio is $150,000.00–$218,000.00.
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